Product News and Recalls

FDA warns of false meningitis cure

The U.S. Food and Drug Administration warns that a company’s claims of treating or curing fungal meningitis with “light therapy” are false.

According to a story posted on the ABC News Website, The Avalon Effect, of Franklin, Tenn., illegally marketed the Quantum Series Personal Wellness Pack as a treatment or cure for fungal meningitis.

The company’s Website claimed the product’s “non-invasive, stress reducing light” relieves the symptoms of meningitis, which is a potentially deadly inflammation of the tissues surrounding the spinal cord and brain.

The U.S. Centers for Disease Control and Prevention list the number of cases in the current fungal meningitis outbreak at 419. The outbreak has affected 19 states, and killed 30 people.

Investigators have traced the outbreak to a Massachusetts-based specialty pharmacy called the New England Compounding Center, which produced a batch of steroid medication containing a fungal contaminant.

Although The Avalon Effect Website now includes a disclaimer that the device isn’t meant to treat or cure disease, earlier claims were illegal because the company has neither an approved application to market it nor an exemption to investigate it for purposes of safety and effectiveness, the FDA said

The agency sent a warning letter to the chief executive officer of the company, warning that the false claims on the Website violate the Federal Food, Drug, and Cosmetic Act.

Lopez McHugh is investigating cases related to this outbreak. If you or a loved one had an injection and were diagnosed with meningitis, you should consult with a Lopez McHugh lawyer for a free consultation.